Product code
QIS: Esophageal, mucosal, electrical characterization
FDA product code · Class II · Gastroenterology/Urology
Key facts
| Product code | QIS |
|---|---|
| Device | Esophageal, mucosal, electrical characterization |
| Device class | Class II |
| Regulation number | 876.1450 |
| Review panel | Gastroenterology/Urology |
| Medical specialty | Gastroenterology/Urology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | The esophageal tissue characterization system is intended for obtaining measurements of electrical properties within esophageal tissue. |
At a glance
- 1–9 510(k) clearances
- 1–9 De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- None MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database